The Following article is a Reprint from the Baltimore Sun, October 5, 2010, original material property of the Baltimore Sun.

Lawyer Alleges Negligence and Fraud in Unneeded Stents at St. Joseph Medical Center in Towson Maryland

By Peter Hermann and Tricia Bishop, The Baltimore Sun

A Towson attorney filed a foot-high stack of claims in a state arbitration office Tuesday on behalf of 101 patients alleging conspiracy, negligence and fraud against St. Joseph Medical Center and its former star cardiologist, Dr. Mark G. Midei, who's accused of performing hundreds of unnecessary cardiac procedures.

The arbitration filings, required before court action, came after settlement talks between the hospital and medical malpractice attorney Jay D. Miller broke down. They represent the first significant wave of litigation involving Midei, who has already been sued in a handful of court filings this year. But more legal action is expected to follow, encompassing doctors at other hospitals.

"I think [the problem is] nationwide," said Miller, who is also looking into potential claims against at least one cardiologist at Union Memorial Hospital in Baltimore.

A state committee revealed last month that a doctor at an unnamed Maryland hospital is currently under investigation and that an inquiry at a third hospital is likely. St. Joseph, Union and Washington Adventist Hospital in Takoma Park have the highest rates of stent placements in Maryland, according to a Baltimore Sun analysis.

Both Union and Washington said in statements to The Sun that they haven't been contacted about any state investigation and that quality care is their chief concern. Union declined to address Miller's claims directly, but said that its doctors perform procedures "according to best practices within the cardiology profession."

Midei is accused of falsifying medical records to make it appear that patients had clogged arteries, then inserting mesh stents into their healthy veins an unwarranted treatment.

St. Joseph removed him from duty last year, shortly after it learned of the allegations. And a physician oversight board filed professional charges against Midei this summer, alleging "gross overutilization of health care services" among other violations of state law.

That case has yet to be resolved, and no criminal charges have been filed against him, though a U.S. Senate Committee is investigating whether Midei's alleged actions involved Medicare fraud. Last year, a Louisiana cardiologist was sentenced to 10 years in federal prison for similar allegations of procedure overuse, and a Salisbury cardiologist was indicted for it this summer.

Several lawsuits were filed earlier this yearin Baltimore County, and one in the city seeking class-actions status. Miller, who says he represents nearly 200 patients, said he wants each of his clients to pursue their own claims.

"I want each person to have his or her day in court," Miller said Monday. "Each case is different. Everybody's damages are different. We're talking about fraud here."

Miller filed theclaims in Maryland's Health Care Alternative Dispute Resolution Office, which arbitrates malpractice cases. Representatives can begin further talks, and either side can appeal in court if it finds the board's decision unsatisfactory. If all sides agree to forgo further talks, the cases can be moved to court without additional meditation.

St. Joseph sent letters to nearly 600 of Midei's former patients, warning them that their stents may have been unnecessary. And the hospital has said it wants to work with patients to settle legitimate claims.

Miller would not discuss specifics regarding his confidential talks with St. Joseph officials, but he said the breakdown occurred over how much money each side thought his clients deserved. He said the hospital offered no more than "out-of-pocket expenses" for medication and follow-up visits to doctors not covered by insurance.

The attorney said the patients deserve more. Depending on individual insurance plans, he said, his clients could be out between $20,000 and $50,000 over the course of their remaining years, in part because the procedure requires they take medications with dangerous side-effects.

In a statement, St. Joseph's said it could not comment on claims that have yet to be filed. But they did confirm they're seeking to talk with patients and their lawyers to try to settle any potential claims. The hospital says that not all patients who received letters had an unwarranted procedure.

The hospital, the statement says,"will take responsibility when patients demonstrate that inappropriate care has caused them an injury. SJMC has invited all the plaintiffs' attorneys to submit supporting medical information so that it can properly and fairly evaluate each claim. SJMC has only received that information in a few cases."

The statement adds that the hospital "respects that some patients want to explore their legal options as a result of receiving a letter regarding their procedure. SJMC had hoped to find common ground with Mr. Miller that would allow for an expedited process to appropriately settle all legitimate claims in a fair manner. Unfortunately, efforts thus far have been unsuccessful."

Midei's attorney, Stephen L. Snyder, said the inability of St. Joseph's to satisfy its patients further harms his client, who denies any wrongdoing.

"The hospital took unprecedented and decisive action in tarnishing and forever destroying Dr. Midei's fine reputation," Snyder said in a statement. "Yet when it comes time to defend these matters, the hospital's conduct frustrates and disappoints these plaintiff's lawyers who are led to believe that the only issue to resolve is how much. It is not."

Miller said the lawsuits will give him a chance to depose key hospital officials and learn more about how Midei allegedly escaped scrutiny. Regulatory documents reported on by The Baltimore Sun in May show that the doctor avoided peer review because, as a department head, he chose which cases would be scrutinized.

State regulators discovered, for example, that in five cases, Midei wrote that patients had 80 percent blockages of coronary arteries, which required stents. But the board found that the arteries were blocked only 50 percent.

Miller, who sought out clients by placing newspaper ads after the letters were sent out, questioned whether St. Joseph officials did all they could to uncover the problem and alleges that the hospital and Midei conspired to perform unnecessary procedures.

"The hospital had to have been aware of what Dr. Midei was doing and they just looked the other way," Miller said. All 104 of his clients filing claims Tuesday received letters from the hospital warning them that they might not have needed the procedure, Miller said.

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Reprinted Baltimore Sun Article

St. Joseph, two others, had highest stent rates Hospitals in Towson, Baltimore and Takoma Park lead Maryland in costly procedure

By Tricia Bishop and Robert Little, The Baltimore Sun

8:23 p.m. EDT, July 3, 2010

Three hospitals have consistently outpaced all others in Maryland in the use of stents to treat heart patients, according to data obtained by The Baltimore Sun, raising questions as state regulators examine whether the expensive procedure is performed unnecessarily by some doctors.

St. Joseph Medical Center in Towson became the subject of a state investigation earlier this year after it notified 585 patients that they might have received unneeded stents to prop open their arteries. The new data, from the Health Services Cost Review Commission, shows that Union Memorial Hospital in Baltimore and Washington Adventist Hospital in Takoma Park are also likely to be subject to review.

Each of the three hospitals exceeded the state's average rate of placing a stent after diagnosis by 20 percent to 30 percent over the past five years. Combined, they placed more than half the stents given to all patients in Maryland.
St. Joseph led Maryland hospitals in both the number of stents placed and the percentage of patients treated with stents after being diagnosed, the data indicates. Stents and related heart procedures generated an average of $81 million in annual charges for St. Joseph over that five-year period. Dr. Mark Midei, who ran the cardiac catheterization lab at St. Joseph until last year, lost his privileges to practice medicine there amid accusations that he had implanted unneeded stents. Since then, St. Joseph is on track to post roughly $55 million in stent-related charges.

The Sun obtained the data through a request under Maryland's public information law. State health officials are using the same information to direct a multi-agency investigation into potentially uncalled-for medical procedures, and have said they are focusing on doctors and facilities with the highest performance rates. State officials plan to complete their review by the fall.

Regulators and area cardiologists caution that high rates of stent placement are not necessarily indicative of overuse, because all three of the top hospitals have cardiac centers that see many of the state's toughest cases and get referrals from other hospitals.

"Based on a cursory review of the data, some may conclude that higher ratios of stents to [diagnostic procedures] may be indicative of unnecessary utilization," Robert Murray, executive director of the commission, wrote in a letter to The Sun. "However, this may well not be the case."

Officials at the three hospitals replied in a similar vein.

"High intervention ratios may need to be evaluated, but no conclusions should be drawn without patient-specific data," St. Joseph said in a statement.

"Cardiologists from around the region refer their most difficult patient cases to our experts," Union Memorial spokeswoman Debra Schindler said in a statement. "This means that our institution regularly treats patients above the average both in terms of volume and severity of their condition."

St. Joseph officials noted a "definable decrease" in the hospital's rate of stent placements since Midei stopped practicing there in May 2009. Union Memorial has also seen a decrease over the past year, bringing stent-placement rates at the competing Baltimore-area hospitals much closer to the state average.

Cardiac catheterization, in which a device is threaded into a patient's arteries to explore blockage, is a $500 million annual business for Maryland hospitals. They performed an average of more than 38,000 procedures in each of the past five years. Stents, mesh tubes that are placed in arteries to treat blockages found during catheterization, were used an average of 13,400 times a year, the state data shows.

At its peak in 2006, St. Joseph placed 3,690 stents, billing an average of more than $14,000 per procedure, records show. Stent use has declined nationwide since about 2007, when results of a large clinical trial showed that treatment with medicine is less dangerous and equally effective for many patients.

Unwarranted treatments are a growing concern throughout the U.S. health care industry, and the federal government estimates that as much as 30 percent of Medicare's $500 billion budget is wasted on them.

President Barack Obama recently called for increased "scrutiny of physicians in high-risk areas or those that order a high volume of high-risk services," according to a White House fact sheet. And several federal investigations are focusing specifically on stent placement, including in Maryland and the District of Columbia.

The state's investigation was spurred by allegations against Midei, who ran the cardiac catheterization program at St. Joseph until the hospital, acting on a patient complaint, reviewed two years' worth of his records and determined that he had placed stents that might not have been necessary in 585 patients. The Maryland Board of Physicians conducted a review and has filed administrative charges to strip the Towson cardiologist of his medical license.

Midei has denied the allegations, and supporters suggest that he is being framed by a vengeful colleague.

When St. Joseph hired Midei in early 2008, the move scuttled a $25 million deal that his former employer, MidAtlantic Cardiovascular Associates, had struck to merge with MedStar Health, the parent company of Union Memorial. At the time, MidAtlantic's CEO told Midei that he would "destroy him personally and professionally," according to court records.

As cardiology business at St. Joseph declined since 2006, it picked up at Union Memorial. Between them, the two hospitals have accounted for more than $760 million in billings for cardiac catheterization and stent procedures since 2005.

Over that period, patients who received a cardiac catheterization were given stents 46 percent of the time at St. Joseph and 44 percent of the time at Union Memorial. The statewide average was 35 percent.

The three hospitals said the disparity results from their specialization dealing with a high volume of complicated heart cases.

Officials at Washington Adventist, where cardiac catheterization patients got stents 43 percent of the time, noted that many of their patients as at St. Joseph and Union Memorial come from other hospitals that are not equipped to place a stent.

"Our stent-to-procedure ratio is reflective of our status as a regional referral hospital for many hospitals in Maryland," the hospital said in a statement.

Among other Baltimore-area hospitals, Johns Hopkins and the University of Maryland Medical Center performed 900 and 750 stent procedures a year, respectively, on average, and each had below-average stent-to-procedure rates. Sinai Hospital placed about 1,100 stents a year, at a rate that roughly mirrored the state average.

Investigators have suggested that the increased attention could be having a chilling effect on the procedure nationwide.

Allegations of improper use have frightened physicians into thinking twice before implanting stents, cardiologists said. Recent studies showing that stents may be less effective and carry more risks than previously thought have also contributed to a drop in their use.

According to a measure developed by state investigators, a typical cardiologist implants a stent in 30 percent of the patients on which he or she performs a cardiac catheterization. Midei and others were doing procedures at nearly twice that rate, the data showed.

But Dr. Thomas Aversano, an associate professor at the Johns Hopkins University School of Medicine and its Heart Institute, sees little meaning in such statistics.

"The methodology is flawed," he said, noting that specialty centers see more complex cases. "It's not because they're crazy and doing angioplasty on everybody."

State law also restricts which hospitals can place the devices, limiting the field. Aversano, who practices at Greater Baltimore Medical Center in Towson, said he cannot implant a stent after a catheterization procedure because the facility isn't equipped for it. He would have to refer the patient to a hospital such as St. Joseph.

But he acknowledged that such a referral is more likely to lead to a stent.

"In my experience, when you have the capability of doing something, that void gets filled," he said

The preceding article is reprinted from the Baltimore Sun

Re-printed from the Baltimore Sun on Januray 25, 2010. When is a Stent Necessary

Whether a stent is needed can be tough call

Measures of blockage in coronary arteries aren't precise

January 25, 2010 |By Kelly Brewington

When patients are in the throes of a heart attack, there's no question that stents save lives.

But for heart patients with few symptoms and less than severe artery blockage, whether to use a stent is a question with no clear-cut answer, say cardiologists. In fact, these days some heart experts say the mesh metal tubes used to keep narrowed or weakened arteries propped open are overused for blockages that can be treated just as well with medicine, a healthy diet and exercise.

A recent internal review of heart patients at St. Joseph Medical Center in Towson found 369 patients received the coronary implants unnecessarily. Those findings have sparked one lawsuit so far and threats of more to come - while highlighting a debate among cardiologists and confusion among patientsover when stents are necessary.

So, what's a patient to do? For those in the middle of a heart attack with unrelenting symptoms, stents are the best option, cardiologists say. But for others, the answers can vary.

"It's not black and white," said Dr. Mark Hlatky, a professor of cardiovascular medicine at Stanford University. "This is a whole shade of gray."

The key for patients is education. Understand your test results, know the options available and ask plenty of questions of your doctor well before you undergo any procedures, cardiologists advise.

Stents are typically placed in an artery after an angioplasty, a procedure in which clogged vessels are cleared with a balloon to restore blood flow to the heart. Stents act as scaffolding, keeping the arteries pushed open so they can stay clear for years after the procedure.

In the 1990s, coronary artery stents were welcomed by doctors and patients alike, offering a less invasive, cheaper alternative to bypass surgery, and an option more effective than angioplasty on its own. Since then, about 1 million stents have been implanted each year in the United States.

But they don't come without risks. Patients must be on blood-thinning medication for a year or longer. There's a risk of complications during stent placement and beyond, including blood clots and heart attack. Once they're put in, stents can't come out.

In recent years, clinical trials have shown medication to be as effective in some circumstances, and an internal debate has been brewing over whether doctors rely too heavily on the implants.

Stents only relieve symptoms; they don't make you live longer, Hlatky said, adding that he falls on the conservative side of the debate. The first question any physician and patient should ask is if interventions are needed at all or whether a person's symptoms could be helped with drugs alone, he said.

If an intervention is needed, the second question should be what kind: a stent or bypass surgery, he said. Bypass surgery is usually reserved for patients with more extensive heart disease and multiple severe blockages, while stents work best for patients with one or two blockages, he said.

"The strategy should be, let's try drugs first," Hlatky said. "If they work, we'll keep using them. If they are not working and you keep having symptoms, we'll go ahead and use an angioplasty [and stent]. But this should not be routine for anyone."

Dr. Monica Aggarwal, a noninvasive cardiologist at Mercy Medical Center, agrees stents should only be used when medicine and lifestyle changes have failed. When a patient comes to her with chest pain, Aggarwal must figure out if it's cardiac pain or something else such as heartburn, muscle pain or a lung problem.

"A patient should be asking: What are my symptoms, are they cardiac or not? What are my risk factors?" she said.

If symptoms indicate pain is coming from the heart, a doctor typically orders a stress test, which evaluates how well the heart is working after exercise. Some stress tests can tell where on the heart that blood flow is stalled.

If the test is abnormal or shows blood flow is restricted in important areas, then a doctor and patient should discuss the options.

"[Patients] should ask, do we need a stress test? What is the stress test looking for?" said Dr. Claudia Hochberg, an interventional cardiologist at Boston Medical Center. "And then, afterward, what kind of abnormality is found?

What's the best way to treat it?"

A normal test may simply require more monitoring. Even with an abnormal result, a patient might do well with medicine and a change in lifestyle, such as quitting smoking, eating better and exercising, she said.

When a stress test reveals that more than one vessel is restricted or blood flow is blocked in a major artery branch on the left side of the heart, most cardiologists will take a closer look to determine how bad the clog is, using cardiac catheterization. In that procedure, a tool is inserted in the leg and threaded up to the heart, Hochberg said.

If the arteries are very clogged, most doctors put in a stent.

But before catheterization, patients and doctors should discuss the options, Hlatky said. When a doctor does the test and finds a significant blockage, most stents are placed immediately, during the same procedure. If a patient has reservations about having a stent put in, at that point, it's too late to discuss them, he said.

"You don't have a lot of time to reflect on this," he said. "The doctor sits there and says, 'I can do this now,' and they do. It's important to have the conversation beforehand."

But for some patients, these steps don't always unfold easily. Determining the severity of a blocked artery isn't an exact science, said Dr. Jon Resar, an interventional cardiologist and director of the adult cardiac catheterization laboratory at Johns Hopkins Hospital.

By clinical guidelines, an artery should be clogged at least 70 percent before a stent should be placed, Resar said. "A 50 percent blockage doesn't need to be stented," he said. "Give them Lipitor, control their blood pressure and have them exercise."But often, catheterization and a coronary angiogram, which takes pictures of the heart vessels, give a doctor a range of a blockage, not an exact number, he said. That wiggle room leaves the decision to use a stent in the hands of the cardiologist doing the procedure, making the device susceptible to overuse, he said.

"There are a lot of intermediate blockages that shouldn't be stented but end up being stented primarily because of financial incentive to the physicians who get paid for doing the procedure,"

Resar said.

Stents are big business for hospitals, which can charge $10,000 or more for the process.

Some insurance carriers are pushing for more stringent justification of stents, Resar said. Techniques that can help include using a pressure wire to help measure whether blockages are significant enough to warrant a stent, he said.

"Then you're not doing unnecessary procedures and not putting stents where they don't need to be," he said. "And you're decreasing costs by only treating blockages that need to be treated."

Still, whether to insert a stent can be a tough call for even the most ethical of clinicians, Aggarwal said.

"Nobody wants to miss heart disease," she said. "It's the No. 1 cause of death in men and women. There may be more aggressiveness on invasive testing because we want to make the right decision for the patient.

"It's not that bad cardiology is being practiced, it's not that we're not making good decisions," she added. "It's just not always clear."

Since a 2007 clinical trial found that drug therapy is often as effective as stents, cardiologists have been re-evaluating the use of the implants, Aggarwal said.

"That was a turning point for us," she said. "We stepped back and said, gosh, medical therapy is really great. Before, you see a blockage, you stent it. It works. It seemed so obvious. But it was a good opportunity for us to step back and say maybe we aren't giving enough consideration to medical therapy."

And even if a patient does end up getting a stent, that shouldn't be seen as the cure-all for a heart problem, Aggarwal said. Exercising, eating a healthful diet and quitting smoking are still crucial.

"Getting any procedure on your heart doesn't give you a free pass to not take care of yourself," she said.

Preceding Article Re-printed from the Baltimore Sun, January 25, 2010.

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